Pilot Study of Radiation-Induced Xerostomia Treatment With Allogeneic Mesenchymal Stromal Stem Cells

February 27, 2026 updated by: Institute of Oncology Ljubljana

A Pilot Study Treating Radiation-Induced Xerostomia Using Allogeneic Mesenchymal Stromal Stem Cells

This pilot interventional study evaluates the safety and preliminary efficacy of treatment with allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue in patients with radiation-induced xerostomia after radiotherapy for head and neck cancer. Xerostomia is a frequent late adverse effect of radiotherapy and can significantly impair oral function and quality of life.

Participants receive a single administration of allogeneic MSCs as the study intervention and are followed for clinical outcomes. The study evaluates safety, salivary gland function, subjective xerostomia symptoms, and imaging-based changes in salivary gland tissue.

The results of this pilot study may support the development of regenerative treatment strategies for radiation-induced salivary gland damage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective pilot interventional clinical study designed to assess the safety and preliminary efficacy of treatment of radiation-induced xerostomia using allogeneic mesenchymal stromal stem cells (MSCs) derived from umbilical cord tissue. Radiation-induced xerostomia is a common late complication in patients treated with radiotherapy for head and neck cancer and is associated with reduced salivary flow, impaired oral health, swallowing difficulties, and decreased quality of life.

Allogeneic MSCs are characterized by strong immunomodulatory properties and regenerative potential. In this study, MSCs obtained from umbilical cord tissue are administered as a therapeutic intervention to evaluate their potential to improve salivary gland function and reduce symptoms of xerostomia.

The primary objective of the study is to assess the safety of MSC administration, with follow-up monitoring for adverse events during a four-month period after the intervention.

Secondary objectives include evaluation of preliminary efficacy of MSC therapy by assessing:

subjective xerostomia symptoms and patient-reported outcomes,

salivary flow and salivary quality parameters,

radiological, scintigraphic, and morphological changes of salivary gland tissue following treatment.

Participants undergo structured clinical evaluations and follow-up assessments according to the study protocol. The study aims to provide early evidence on feasibility and potential clinical benefit of MSC-based therapy for the treatment of radiation-induced xerostomia.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • History of radiotherapy for head and neck cancer
  • Presence of radiation-induced xerostomia
  • Completed oncological treatment
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Active malignant disease requiring ongoing oncological treatment
  • Acute infection or inflammation in the oral cavity or salivary glands
  • Severe systemic disease or condition that could influence study results
  • Contraindication to the planned intervention (MSC administration)
  • Pregnancy or breastfeeding
  • Any condition that, in the investigator's opinion, would interfere with participation or evaluation of outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allogeneic MSC Treatment for Radiation-Induced Xerostomia
Participants with radiation-induced xerostomia following radiotherapy for head and neck cancer receive a single administration of allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue. The intervention is performed according to the study protocol, and participants are prospectively followed to assess safety and preliminary efficacy, including salivary gland function, salivary quality, imaging findings, and patient-reported outcomes related to xerostomia.
Biological: Allogeneic Mesenchymal Stromal Cells (MSC)
Allogeneic mesenchymal stromal cells (MSC) derived from umbilical cord tissue are administered to participants with radiation-induced xerostomia following radiotherapy for head and neck cancer. The intervention is performed according to the study protocol to evaluate safety and preliminary efficacy. Participants are monitored for adverse events and changes in salivary gland function, saliva quality, imaging findings, and xerostomia-related symptoms during follow-up.
Other Names:
  • Umbilical Cord-Derived MSC
  • Allogeneic UC-MSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events of Allogeneic MSC Treatment for Radiation-Induced Xerostomia
Time Frame: From intervention through 4 months after the intervention
Safety is assessed by the incidence, type, and severity of adverse events and serious adverse events following administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSC) in participants with radiation-induced xerostomia.
From intervention through 4 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI-XEROSTOMIA-MSC-2023
  • ERID-KSOPR-0026/2023 (Other Identifier: Institute of Oncology Ljubljana (KSOPR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Allogeneic Mesenchymal Stromal Cells (MSC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe